VOCSN Patient Breathing Package PRT-00805-001

GUDID 00855573007686

VOCSN Patient Breathing Package (Pediatric, Passive, Heated, Oxygen, Blue)

VENTEC LIFE SYSTEMS, INC.

In-exsufflator

• Primary Device ID: 00855573007686
• NIH Device Record Key: c4e90fee-b316-4730-9621-87c81c55596a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VOCSN Patient Breathing Package
• Version Model Number: Pediatric, Passive, Heated, Oxygen, Blue
• Catalog Number: PRT-00805-001
• Company DUNS: 078758082
• Company Name: VENTEC LIFE SYSTEMS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00855573007679 [Primary]
GS1	00855573007686 [Package]; Contains: 00855573007679; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162877

FDA Product Code

• BZE: Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-01-31
• Device Publish Date: 2018-07-11

On-Brand Devices [VOCSN Patient Breathing Package]

• 00855573007686: VOCSN Patient Breathing Package (Pediatric, Passive, Heated, Oxygen, Blue)
• 00855573007662: VOCSN Patient Breathing Package (Pediatric, Passive, Oxygen, Blue)
• 00855573007648: VOCSN Patient Breathing Package (Pediatric, Passive, Heated, Blue)
• 00855573007709: VOCSN Patient Breathing Package (Pediatric, Passive, Blue)
• 00855573007617: VOCSN Patient Breathing Package (Pediatric, Active, Heated, Oxygen, Blue)
• 00855573007594: VOCSN Patient Breathing Package (Pediatric, Active, Oxygen, Blue)
• 00855573007570: VOCSN Patient Breathing Package (Pediatric, Active, Heated, Blue)
• 00855573007556: VOCSN Patient Breathing Package (Pediatric, Active, Blue)
• 00855573007358: VOCSN Patient Breathing Package (Pediatric, Valveless, Heated, Blue)
• 00855573007266: VOCSN Patient Breathing Package (Adult, Valveless, Heated, Blue)
• 00855573007259: VOCSN Patient Breathing Package (Adult, Valveless, Blue)
• 00855573007365: VOCSN Patient Breathing Package (Pediatric, Valveless, Blue)
• 00855573007334: VOCSN Patient Breathing Package (Adult, Passive, Heated, Blue)
• 00855573007327: VOCSN Patient Breathing Package (Adult, Active, Heated, Blue)
• 00855573007310: VOCSN Patient Breathing Package (Adult, Passive, Blue)
• 00855573007068: VOCSN Patient Breathing Package (Adult, Passive, Heated, Oxygen, Blue)
• 00855573007051: VOCSN Patient Breathing Package (Adult, Active, Heated, Oxygen, Blue)
• 00855573007280: VOCSN Patient Breathing Package (Adult, Passive, Oxygen, Blue)
• 00855573007242: VOCSN Patient Breathing Package (Adult, Active, Oxygen, Blue)
• 00855573007020: VOCSN Patient Breathing Package (Adult, Active, Blue)
• 00855573007938: VOCSN Patient Breathing Package (Adult, Active, Heated, Blue)
• 00855573007891: VOCSN Patient Breathing Package (Adult, Active, Blue)
• 00850018761079: VOCSN Patient Breathing Package (Adult, Active, Heated, Oxygen, Blue)
• 00850018761055: VOCSN Patient Breathing Package (Adult, Active, Oxygen, Blue)